Systems for soft tissue repair

ABSTRACT

Systems for tissue repair are described where an elongate tissue repair device may be introduced into a single incision to access the damaged tissue. A suture delivery assembly may be sized for insertion through a single incision and positioned into proximity with a damaged or ruptured tissue region. A first portion of the damaged tissue region may be positioned within or along a channel defined along the suture delivery assembly and one or more lengths of suture may be secured to the first portion via the device. A second portion of the damaged tissue region may be similarly positioned within or along the channel and one or more additional lengths of suture may be secured to the second portion via the device. The first and second portions may then be approximated and secured to one another via the sutures to facilitate healing of the damaged tissue region.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/936,879, filed on Jul. 8, 2013, which is acontinuation-in-part of U.S. patent application Ser. No. 13/711,297, nowU.S. Pat. No. 9,173,654, filed Dec. 11, 2012, the disclosures of whichare incorporated herein by reference in their entireties.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methodsused for attaching soft tissues to one another. More particularly, thepresent invention relates to apparatus and methods for re-attaching adamaged tissue region to one another such as a ruptured Achilles tendonin a minimally invasive manner.

BACKGROUND OF THE INVENTION

Soft tissue damage, particularly tendon rupture such as the Achillestendon, is typically a debilitating event. Surgical repair of a rupturedtendon generally requires the torn or ripped ends of the tendon, whichare separated from one another, to be coapted by passing one or moresutures through each damaged end. Each of the torn ends are drawntowards one another by tightening of the sutures to restore theconnecting muscles and tendon to their original lengths.

However, accessing the damaged tissue generally requires relativelylarge incisions or multiple smaller incisions for effecting adequatepurchase and sufficient suturing of the damaged tendon to ensure properhealing of the tendon. Yet relatively large incisions or multipleincisions also increase the likelihood of infections and complicationsoccurring.

Moreover, minimally invasive devices which may be inserted throughrelatively smaller incisions are generally limited in their applicationfor repairing particular tissue regions. For instance, minimallyinvasive surgical instruments may enable a surgeon to pass suturesthrough tissue with the instruments introduced through relatively smallincisions; however, these instruments are limited in their ability topass multiple sutures through non-supported tissue structures in anefficacious manner.

Moreover, may such devices are insufficient in supporting tissuestructures such as ruptured or torn tendons for minimally invasivesurgical repair. Thus, tissue repair systems which are able to pass oneor more sutures in a minimally invasive manner into tissue structures,such as the Achilles tendons, which are difficult to secure andmanipulate are highly desirable.

BRIEF SUMMARY OF THE INVENTION

A suture delivery assembly may be sized for insertion through a singleincision and positioned into proximity with a damaged or ruptured tissueregion. Generally, one variation of such a tissue repair system maycomprise a handle having an actuator, a suture delivery assembly coupledto the handle and defining a tissue receiving channel along the suturedelivery assembly, one or more needles which are curved or arcuate andwhich are rotatable from a delivery position to a deployment positionwhere the one or more needles are rotatable at least partially throughthe tissue receiving channel when articulated by the actuator, and oneor more lengths of suture which carried by the one or more needles.Additionally, one or more stylets which are translatable through thesuture delivery assembly may be inserted into proximity to the one ormore needles where each of the needles may define a clearance slot whichis sized to partially receive the one or more stylets when each of theone or more needles are aligned relative to one another in thedeployment position.

In use for repairing a tissue region, generally a suture deliveryassembly defining a tissue receiving channel therealong may beintroduced through an incision in proximity to a ruptured or torn tissueand positioned relative to a first portion of the ruptured or torntissue such that the tissue is positioned within the tissue receivingchannel. The one or more needles within the suture delivery assembly maybe rotated from a delivery position within the suture delivery assemblyto a deployment position such that the one or more needles pierce intoand through the damaged tissue positioned within the tissue receivingchannel. As the one or more needles pierce through the tissue, one ormore corresponding lengths of suture may be passed through the tissuevia the needles.

Then, at least one stylet may be inserted through the suture deliveryassembly and through at least one stylet clearance slot defined alongthe one or more needles to deliver a length of suture, which may becommon with the suture passed through the tissue or which may be aseparate length of suture. The needles may be retracted and the assemblyremoved leaving the one or more sutures behind in the tissue in aprescribed suturing pattern. The sutures may then be tightened to thetissue. This process may be repeated on a second portion of the rupturedor torn tissue and the resulting sutures from the second portion may besecured to the sutures from the first portion to reattach the rupturedtissue.

Examples of devices and methods which may be used with the devices andmethods described herein are further disclosed in detail in U.S. patentapplication Ser. No. 13/113,505 filed May 23, 2011 (U.S. Pub.2011/0313454 A1) and U.S. Prov. App. 61/349,025 filed May 27, 2010, eachof which is incorporated herein by reference in its entirety for anypurpose.

In one example, a tissue repair assembly may have a handle housing andan actuator which is actuatable and is operatively coupled to a suturedelivery assembly designed for percutaneous insertion through anincision. The suture delivery assembly may be sized for subcutaneousplacement while contacting the underlying tissue to be treated. Theassembly may have a height, e.g., of less than 2 cm, a width, e.g., ofless than 3 cm, and a length, e.g., of less than 7 cm. The suturedelivery assembly has an atraumatic distal end and external shellassembly comprised of a first portion of external shell attachable to asecond portion of the external shell both which may surround a needlehousing assembly. The suture delivery assembly may be generallyconfigured to define a tissue receiving portion for contacting thetissue to be treated where the tissue receiving portion faces away fromthe handle housing.

The needle assembly itself may be comprised of a first set needles,e.g., three curved or arcuate needles, which are positioned adjacent toone another and a second set of needles, e.g., three curved or arcuateneedles which are also positioned adjacent to one another. Each of thefirst set of needles and second set of needles may be positioned inapposition to one another such that each needle is staggered relative toone another. Moreover, each of the first and second set of needles maybe rotatably positioned within the needle housing assembly to rotaterelative to the housing assembly and traverse through the tissuereceiving portion for piercing through and passing suture through thecontacted tissue.

In one example of use such as with a ruptured or torn tendon such as theAchilles tendon, a single incision, e.g., less than 3 cm in length, maybe made in the patient leg in proximity to or between the torn tissueportions. Because the suture delivery assembly may have a housingvolume, e.g., of less than 17 cc to 30 cc, the assembly may be insertedthrough the incision, e.g., up to an insertion distance of less than 5cm, such that the tissue receiving channel may contact the first portionof tissue, e.g., a proximal portion of a ruptured Achilles tendon.Because the channel diameter may be sized or adjusted, e.g., between 0.5cm to 2 cm, to accommodate various size tissue diameters, the damagedfirst portion of tissue may be securely retained by the assembly whichmay pass the needles through the tissue to deliver one or more lengthsof suture in proximity to the first ruptured segment.

Once the tissue has been positioned and/or temporarily secured within oragainst the tissue repair assembly, the handle may be actuated to rotaterespective actuation shaft upon which the needles are secured inopposing directions which in turn rotates each of the needle assembliesfrom within the housing assembly and into and through the tissue. Aseach of the needles pass through the tissue, they may each pass portionsof a common length of suture entirely through the tissue. Moreover, thedistal tips of each of needle may rotate through the tissue receivingchannel (and through any tissue present) to converge along or inproximity to a common longitudinal axis along the assembly. Once theneedles have passed their respective portions of suture through thetissue, a stylet may then pass a terminal suture end (or another lengthof suture) through each of the suture portions aligned along or inproximity to the common longitudinal axis for further tightening andsecurement.

With the first portion of tissue secured, the tissue repair assembly maybe removed from the incision and the same suture delivery assembly withadditional lengths of suture (or a second assembly) may be re-introducedin the opposing direction through the incision to contact the secondportion of tissue, e.g., the distal portion of ruptured tendon. Thesuture delivery assembly may then be secured to the second portion oftissue with the resulting second suture configuration in proximity tothe second ruptured segment. The suture delivery assembly may then beremoved and the terminal ends of the first suture and second sutureconfiguration may be tied to one another through the incision toapproximate and secure the first ruptured segment and second rupturedsegment against one another to facilitate healing.

Each of the needles may be arcuate or otherwise curved, e.g., in asemi-circular manner, such that each of the needles may be positionedentirely within the needle housing assembly during initial insertion andplacement within the tissue. The curvature of the needle may allow forthe needles to be rotated within a plane which is transverse to alongitudinal axis of the housing assembly such that the needle may berotated through an angle of needle engagement, e.g., 120° or more. Thisallows for the needle proximal end to be driven for the needle piercingtip to be rotated from an enclosed position to one where the distalpiercing tip of the needle is advanced through a corresponding needleopening defined along tissue receiving channel and into a needlereceiving channel. As the piercing tip passes through the tissuereceiving channel along a circular needle trajectory, each piercing tipof each needle may pass a length of suture through the tissue. Theposition of the housing assembly 22 be maintained relative to the tissueto be treated via the handle attachment.

The tissue receiving channel may be varied in size or adjusted tofacilitate temporarily clamping upon the tissue but may generally have adiameter of about 1.25 cm in one variation. Moreover, the diameters ofthe curved needles may also vary but generally may range anywhere from,e.g., 1 cm to 1.5 cm, in this and other variations. Additionally, eachof the needles may be advanced simultaneously, e.g., each of the firstand second needle assemblies along both sides may be advanced throughthe tissue at the same time. Alternatively, the needles may be deployedsequentially along either side (e.g., sequentially along a single side)or both sides (e.g., sequentially along alternating sides) or any othernumber of deployment sequences depending upon the desired sequence ofneedle deployment. Moreover, the order of needle deployment may bevaried in this variation as well as any of the other variationsdescribed herein. Furthermore, the stylet channel may be defined throughthe length of the housing where the stylet channel is coincident withthe longitudinal axis in proximity to where each of the needle distaltips converges.

The needle piercing tips may further define a stylet clearance slotdefined along each needle body proximal to the piercing tip. The styletclearance slot provides for passage of the stylet in proximity to thedeployed needles when the stylet is used to pass the suture through thesuture loops passed by each needle through the tissue.

In another, an adjustable housing assembly may have two adjacent housingassemblies defining a tissue receiving channel therebetween. The housingassemblies may be movably adjusted relatively away or towards oneanother to accommodate various size tissues to be treated. Moreover, theadjustability of the housing assemblies may also allow for the tissue tobe stabilized relative to the housing assemblies by temporarily clampingthe assemblies upon the tissue while the needles and suture are driveninto and through the tissue.

Once the repair device has been inserted in proximity to the tissueregion to be treated, the housing may be articulated via actuationhandles such that the housing pivots about the one or more biasingmembers to place the presentation surfaces defining the tissue receivingchannel securely around the tissue of interest. With the tissuepositioned within the tissue receiving channel, the housing positioningrelative to the tissue may be further adjusted, if so desired. Each ofthe needles may have one or more lengths of suture positioned along eachneedle body and between each adjacent needle. Once the device has beendesirably positioned relative to the tissue, the needles may be actuated(simultaneously or sequentially, as described herein) such that theneedles are rotated by the actuation shafts. The piercing tips of theneedles may accordingly exit the needle openings defined along thepresentation surfaces and traverse through the tissue receiving channelin a circular curve or arc trajectory.

As the needles traverse through the channel and tissue, the needles maypass the suture loops through the tissue and into proximity to thestylet channels defined longitudinally through respective housing. Aspreviously described, the needles may define a notched or cut-outsection as a stylet clearance slot which aligns with the stylet channelswhen the needles have been fully rotated into their deployedconfiguration. Once the needles have carried the suture lengths andsuture loops through the tissue and into proximity to the styletchannels, the stylet (which carries a length of the suture) mayaccordingly be passed through the stylet channel to route the suturethrough the suture loops for further tightening of the suture upon thetissue. Once the suture loops have been passed via the needles, theneedles may be retracted proximally back through the tissue and into thehousing for disengaging the tissue and subsequent removal of the devicefrom the tissue region.

Turning now to the needle assemblies, the number and relativepositioning of the needles may be varied. Although the needles may be ina staggered and alternating configuration, the needles may be moreclosely aligned such that the needle tips are immediately adjacent toone another. Alternatively, the needles may be arranged in a staggeredconfiguration farther apart from one another depending upon the desiredsuturing pattern.

Regardless of the number of needles used and the relative positioning ofthe needles, the needles may be configured and positioned relative tothe tissue receiving channel such that the needles may penetrate intoand through any number of varying tissue sizes. Regardless of the tissuesize, the tissue may be positioned within the tissue receiving channelsuch that when the needle is deployed, its piercing tip may enter thetissue through a tissue entry along a side portion of the tissue andpierce through the tissue at a tissue exit located along a top portionof the tissue where the side and top are relative to the tissue positionrelative to the tissue receiving channel.

The needle may pass a length of suture carried via the suture guide exitentirely through the tissue regardless of tissue size. With the suturepassed through, the stylet may be introduced through the suture loopformed by the suture and left when the needle piercing tip is retractedand the suture falls out of the suture guide exit.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of an exploded suture deliveryassembly attachable to a handle.

FIGS. 2A and 2B illustrate an example of how a suture delivery assemblymay be introduced percutaneously for attaching one or more sutures to afirst portion of a damaged or ruptured tendon.

FIGS. 2C to 2E illustrate how the suture delivery assembly may be usedfor attaching one or more sutures to a second portion of a damaged orruptured tendon and how the damaged ends may be approximated and securedto one another.

FIG. 3 illustrates a detailed perspective view of another variation ofthe suture delivery assembly.

FIGS. 4A and 4B illustrate end views of variations of the suturedelivery assembly.

FIGS. 5A to 5C illustrate respective top, side, and end views of anothervariation of the suture delivery assembly.

FIG. 6A illustrates another variation of the suture delivery assembly.

FIG. 6B illustrates yet another variation of the suture deliveryassembly having a relatively smaller housing.

FIGS. 7A to 7C illustrate respective top, side, and bottom views of avariation of the suture delivery assembly.

FIGS. 7D and 7E illustrate respective end views of the assembly of FIGS.7A to 7C.

FIGS. 8A and 8B illustrate perspective views of the proximal and distalends of the assembly of FIGS. 7A to 7C.

FIGS. 9 and 10 illustrate perspective and end views of the assemblyhousing from the variation of FIGS. 7A to 7C.

FIGS. 11A and 11B illustrate perspective and detail views of theassembly of FIGS. 7A to 7C.

FIG. 12 illustrates a perspective view of yet another variation of thesuture delivery assembly.

FIG. 13 illustrates a perspective view of yet another variation of thesuture delivery assembly.

FIG. 14 illustrates a perspective view of yet another variation of thesuture delivery assembly having a dual housing embodiment.

FIGS. 15A and 15B illustrate partial cross-sectional end views showingthe adjustment between the dual housing and the actuation of therespective needle assemblies.

FIGS. 16A and 16B illustrate partial cross-sectional end views ofanother variation for adjusting the dual housing.

FIG. 17 illustrates a detail perspective view of one example for routingthe suture through the needle assembly between each adjacent needle.

FIG. 18 illustrates a perspective view of another variation of the dualhousing embodiment with the structure partially removed for clarity.

FIGS. 19A and 19B illustrate end and detail end views of an example ofthe needle clearance and interaction relative to a stylet carrying alength of suture.

FIGS. 20A and 20B illustrate end views of yet another variation furtherillustrating an example of how the needle clears the stylet.

FIGS. 21A and 21B illustrate respective end and detail perspective viewsof yet another variation of a needle having a groove or channel forsuture management.

FIGS. 22A and 22B illustrate respective end and detail perspective viewsof yet another variation of a needle having a suture guide for suturemanagement.

FIG. 23 illustrates a side view of yet another variation of a needleincorporating a projection for proximal to the stylet for facilitatingsuture management.

FIGS. 24A and 24B illustrate partial cross-sectional end views ofvariations for actuating the needle assembly.

FIG. 25 schematically illustrates an example for transferring anactuation force from the handle to the needle assembly.

FIG. 26A illustrates a perspective view for one variation of a handleassembly for securing the suture delivery assembly to the tissue to betreated via a cable tightening mechanism.

FIG. 26B illustrates a perspective view for another variation forsecuring the device to the tissue via a squeezable handle.

FIG. 26C illustrates a perspective view for another variation forsecuring the device to the tissue via a translatable handle.

FIG. 26D illustrates a perspective view for another variation forsecuring the device to the tissue via a ring handle.

FIG. 26E schematically illustrates the rotational range of movement ofthe suture delivery assembly for adjustment upon the tissue to betreated.

FIG. 26F schematically illustrates an example of a mechanism fortranslating an actuation force into a clamping force upon the tissue tobe treated.

FIG. 27 illustrates a perspective assembly view of another variation ofthe needle assembly and the respective relative placement.

FIG. 28 schematically illustrates an end view of an example of how theneedle may be used with a range of tissue sizes.

FIG. 29 illustrates a side view of another needle variation having asuture guide.

FIG. 30 illustrates a side view of yet another needle variation having adual piercing tip.

FIGS. 31A and 31B illustrate front and detail side views of anotherneedle variation having a stylet clearance channel and suture guide.

FIGS. 32A and 32B illustrate front and detail side views of anotherneedle variation having a relatively greater angle and needle length.

FIGS. 33A and 33B illustrate front and detail perspective views of aneedle variation showing how the suture is pulled through the tissuewith the suture guide.

FIGS. 34A and 34B illustrate front and detail perspective views ofanother needle variation showing a needle having a slot for facilitatingthe temporary securement and release of the suture through the tissue.

FIGS. 35A to 35C illustrate front and perspective views of anotherneedle variation showing a needle having a flexible suture guidance arm.

FIGS. 36A to 36C illustrate front and perspective views of yet anotherneedle variation of a needle having a split piercing tip.

FIG. 37 illustrates a perspective view of another needle variationhaving a dual piercing and cutting tip.

FIG. 38 illustrates a perspective view of yet another needle variationhaving a cutting edge positioned transversely relative to the needlebody.

FIGS. 39A to 39C illustrate alternative perspective views of a suturedelivery assembly configured to provide a visual indication of when theneedles have completely traversed through the tissue being treated.

FIG. 40A illustrates a variation of the tissue repair assembly having ahandle assembly which may be used with either a lengthened or shortenedsuture delivery assembly.

FIGS. 40B and 40C illustrate perspective views of a tissue repairassembly having either a lengthened or shortened suture deliveryassembly coupled.

FIGS. 41A to 41C illustrate respective side, end, and top views of thetissue repair assembly.

FIGS. 42A to 42C illustrate side, end, and exploded assembly views ofone variation of the handle assembly.

FIGS. 43A to 43C illustrate detail perspective, side, and end views ofone of the connector assemblies to which the handle assembly may becoupled.

FIG. 44 illustrates a detail perspective view of the repair assemblywith the connector assemblies removed for clarity.

FIG. 45 illustrates the needle assemblies with their housing removed forclarity.

FIG. 46 illustrates an exploded assembly view of one of the housingassemblies.

FIGS. 47A and 47B illustrate bottom and end views of one of the housingassemblies.

FIGS. 48A and 48B illustrate perspective views of the suture basketwhich may be positioned within the distal end of the receiving channel.

FIGS. 49A and 49B illustrate side and perspective views of oneparticular variation of the housing assembly.

FIGS. 50A to 50C illustrate end view of the housing assembly variationhaving the atraumatic tip and further illustrating the respectivepositioning of the needle actuation shafts.

DETAILED DESCRIPTION OF THE INVENTION

Ruptured or torn tendons in particular may be difficult to repair due tothe fibrous and relative toughness of these tissues. Additionally,ruptured or torn tendons may be unsupported within the body thusrequiring the securement and approximation of the torn edges towards oneanother. A suture delivery assembly may be sized for insertion through asingle incision and positioned into proximity with a damaged or rupturedtissue region. A first portion of the damaged tissue region may bepositioned within or along a channel defined along the suture deliveryassembly and one or more lengths of suture may be secured to the firstportion via the device. A second portion of the damaged tissue regionmay be similarly positioned within or along the channel and one or moreadditional lengths of suture may be secured to the second portion viathe device. The first and second portions may then be approximated andsecured to one another via the sutures to facilitate healing of thedamaged tissue region.

Although described in reference to the suturing and repair of tendons,particularly the Achilles tendon, the devices and methods describedherein may be utilized on other tissue regions. Moreover, examples ofsuch devices and methods of use are further described in detail in U.S.patent application Ser. No. 13/113,505 filed May 23, 2011 (U.S. Pub.2011/0313454 A1) and U.S. Prov. App. 61/349,025 filed May 27, 2010, eachof which is incorporated herein by reference in its entirety for anypurpose.

Turning now to the perspective view of FIG. 1, an example of a tissuerepair assembly 10 is illustrated having a handle housing 12 and handlegrip 14. An actuator 16 is actuatable relative to the housing 12 and isoperatively coupled to a suture delivery assembly 18 which is designedfor percutaneous insertion through an incision. The suture deliveryassembly 18 may be sized for subcutaneous placement while contacting theunderlying tissue to be treated. Hence, the assembly 18 may have aheight, e.g., of less than 2 cm, a width, e.g., of less than 3 cm, and alength, e.g., of less than 7 cm. The suture delivery assembly 18 has anatraumatic distal end and external shell assembly 20 comprised of afirst portion of external shell 20A attachable to a second portion ofexternal shell 20B both which may surround a needle housing assembly 22.The suture delivery assembly 18 may be generally configured to define atissue receiving portion for contacting the tissue to be treated wherethe tissue receiving portion faces away from the handle housing 12 inone variation, as described below in further detail.

The needle housing assembly 22 may be comprised of a first portion ofneedle housing 22A and a second portion of needle housing 22B, in onevariation, which may at least partially enclose a needle assembly 24.The needle assembly 24 itself may be comprised of a first set needles24A, e.g., three curved or arcuate needles, which are positionedadjacent to one another and a second set of needles 24B, e.g., threecurved or arcuate needles which are also positioned adjacent to oneanother. Each of the first set of needles 24A and second set of needles24B may be positioned in apposition to one another such that each needleis staggered relative to one another. Moreover, each of the first andsecond set of needles 24A, 24B may be rotatably positioned within theneedle housing assembly 22 to rotate relative to the housing assembly 22and traverse through the tissue receiving portion for piercing throughand passing suture through the contacted tissue, as described in furtherdetail below.

In one example of use such as the repair of soft tissue, FIGS. 2A and 2Cillustrate how the tissue repair assembly 10 may be utilized. In theexample of a ruptured or torn tendon such as the Achilles tendon, asingle incision 30, e.g., less than 3 cm in length, may be made in thepatient leg P in proximity to or between the torn tissue portions.Because the suture delivery assembly 18 may have a housing volume, e.g.,of less than 17 cc to 30 cc, the assembly may be inserted through theincision 30, e.g., up to an insertion distance of less than 5 cm, suchthat the tissue receiving channel may contact the first portion oftissue AT1, e.g., a proximal portion of a ruptured Achilles tendon.Because the channel diameter may be sized or adjusted, e.g., between 0.5cm to 2 cm, to accommodate various size tissue diameters, the damagedfirst portion of tissue AT1 may be securely retained by the assembly 18which may pass the needles through the tissue AT1 to deliver one or morelengths of suture in proximity to the first ruptured segment RP1.

Once the tissue has been positioned and/or temporarily secured within oragainst the tissue repair assembly 10, the handle may be actuated torotate respective actuation shaft upon which the needles are secured inopposing directions which in turn rotates each of the needle assembliesfrom within the housing assembly and into and through the tissue. Aseach of the needles pass through the tissue, they may each pass portionsof a common length of suture entirely through the tissue. Moreover, thedistal tips of each of needle may rotate through the tissue receivingchannel (and through any tissue present) to converge along or inproximity to a common longitudinal axis along the assembly. Once theneedles have passed their respective portions of suture through thetissue, a stylet may then pass a terminal suture end (or another lengthof suture) through each of the suture portions aligned along or inproximity to the common longitudinal axis for further tightening andsecurement.

The manner in which the suture lengths are passed through the tissue andsecured may be utilized in each of the variations described herein andare not limited to any particular embodiment. FIG. 2B illustrativelyshows the ruptured first portion of tissue AT1 with the resulting firstsuture configuration ST1 secured to the tissue by the delivery assembly18.

With the first portion of tissue AT1 secured, the tissue repair assembly10 may be removed from the incision 30 and the same suture deliveryassembly 18 with additional lengths of suture (or a second assembly) maybe re-introduced in the opposing direction through the incision 30 tocontact the second portion of tissue AT2, e.g., the distal portion ofruptured tendon, as shown in FIG. 2C. The suture delivery assembly 18may then be secured to the second portion of tissue AT2 with theresulting second suture configuration ST2 in proximity to the secondruptured segment RP2, as shown in FIG. 2D. The suture delivery assembly18 may then be removed and the terminal ends of the first suture ST1 andsecond suture configuration ST2 may be tied to one another through theincision 30 to approximate and secure the first ruptured segment RP1 andsecond ruptured segment RP2 against one another to facilitate healing,as shown in FIG. 2E.

Various embodiments of the suture delivery assembly and needle housingassembly may be utilized. Another example is illustrated in theperspective view of FIG. 3 which shows a partial cross-sectional needlehousing assembly 22 (for clarity) having a curved outer surfacesymmetrically configured around a tissue receiving channel 40 which maybe semi-circular in cross-section or curved into a receiving portion forcontacting and at least partially enveloping the tissue to be sutured.The housing assembly 22 may curve into a flared configured which definesthe tissue receiving channel 40 such that the first needle assembly 24Ais aligned along a first side of the housing assembly 22 and the secondneedle assembly 24B is aligned along a second side of the housingassembly 22 such that each of the needles are aligned to follow acorresponding needle guide 44A, 44B such that the needles may rotatealong a curved needle channel 42 within the housing assembly 22.

Although three needles 24A are shown positioned along the first side ofhousing assembly 22 and three needles 24B are shown positioned along thesecond side of housing assembly 22, additional needles may also beutilized as practicable depending upon the tissue region to be treated.

Each of the needles may be arcuate or otherwise curved, e.g., in asemi-circular manner, such that each of the needles may be positionedentirely within the needle housing assembly 46 during initial insertionand placement within the tissue. The curvature of the needle may allowfor the needles to be rotated within a plane which is transverse to alongitudinal axis of the housing assembly 22 such that the needle may berotated through an angle of needle engagement Θ, e.g., 120° or more, asshown in the partial cross-sectional end view of FIG. 4A. This allowsfor the needle proximal end 56 to be driven for the needle piercing tip54 to be rotated from an enclosed position to one where the distalpiercing tip 54 of the needle is advanced through a corresponding needleopening 48 defined along tissue receiving channel 40 and into a needlereceiving channel 50. As the piercing tip 54 passes through the tissuereceiving channel 40 along a circular needle trajectory 52, eachpiercing tip 54 of each needle may pass a length of suture through thetissue. The position of the housing assembly 22 may be maintainedrelative to the tissue to be treated via the handle attachment 58.

Another variation of the needle housing assembly 60 is illustrated inthe end view of FIG. 4B which shows a curved and flared housing assembly60 with a tissue of interest 66 being treated while positioned along thetissue receiving channel 40. At least a first needle 62 and a secondneedle 64 are shown as having been advanced from the housing assembly 60and rotated through tissue 66 along respective opposing side portionsand out through a portion of the tissue between the needles and alongthe receiving channel 40 while carrying lengths of suture along eachneedle through the tissue for securement. The tissue receiving channel40 may be varied in size or adjusted to facilitate temporarily clampingupon the tissue but may generally have a diameter of about 1.25 cm inone variation. Moreover, the diameters of the curved needles may alsovary but generally may range anywhere from, e.g., 1 cm to 1.5 cm, inthis and other variations.

Each of the needles may be advanced simultaneously, e.g., each of thefirst and second needle assemblies along both sides may be advancedthrough the tissue at the same time. Alternatively, the needles may bedeployed sequentially along either side (e.g., sequentially along asingle side) or both sides (e.g., sequentially along alternating sides)or any other number of deployment sequences depending upon the desiredsequence of needle deployment. Moreover, the order of needle deploymentmay be varied in this variation as well as any of the other variationsdescribed herein.

FIGS. 5A to 5C illustrate top, side, and end views, respectively, of yetanother variation of the housing assembly 60. The distal end 70 is shownas having an atraumatic blunt end as well as the proximal end 72 whichis connected to handle attachment 58 to the housing assembly 60 viaattachment 74. Each of the curved needles may travel along acorresponding needle guide 44A, 44B and they may be arranged in astaggered pattern which allows for the distal tips of each needle tocross one another such that the lengths of suture carried by each needlemay be secured to one another after being passed through the tissue. Thepartial cross-sectional end view of FIG. 5C illustrates how the needlesmay be advanced into the tissue receiving channel through respectiveneedle openings 76, 78.

FIG. 6A illustrates a perspective view of yet another variation of thetissue repair assembly with a needle housing assembly 80 which isrelatively flat. In this variation, two actuation handles may be used toactuate the needle assemblies. A single actuation handle 82 isillustrated as being attached to needle actuation shaft 84 and a secondactuation handle is shown removed from needle actuation shaft 86 forclarity. An exposed actuation assembly 88 is also illustrated on adistal end of the device also for clarity. In this variation, a singlestylet 89 which may hold a length of suture, such as a free end of thesuture which is passed through the tissue via the needle assemblies, maybe advanced through the needle housing assembly 80 and between each ofthe needle ends after being passed through the tissue. The stylet 89 maythus pass the suture through loops of suture passed through and engagedto the tissue for further tightening and/or securement to thecorresponding suture on the apposed damaged tissue.

FIG. 6B shows yet another variation of the needle housing assembly 90which may have a housing which is relatively smaller in size and widththan the variation of FIG. 6A. In this example, the needle receivingchannel 92 is illustrated as housing the first needles 96A and secondneedles 96B positioned in apposition relative to one another. FIGS. 7Ato 7C illustrate respective top, side, and bottom views of the tissuerepair assembly and further shows each of the needles 96A, 96B havingrespective first piercing tips 98A and second piercing tips 98B in theirdeployed configuration where the needles 96A, 96B have been rotated fromtheir delivery position from within the housing. With the tissuereceiving channel 94 positioned along the bottom of the housing assembly90 for contact against the tissue to be secured, the first and secondpiercing tips 98A, 98B may rotate through the channel 94 (and throughany tissue present) to converge along or in proximity to the commonlongitudinal axis of the assembly as indicated by the stylet channel100. The stylet 89 carrying a suture length may be passed through eachrespective suture loop carried by each needle passed through the tissue.

FIGS. 7D and 7E illustrate proximal and distal end views of the assemblyto show how the one or more handles (only one handle 82 is shown forclarity) may be rotated to actuate the rotation of the respective shafts84, 86 which in turn rotates each of the needles 96A, 96B. Theconvergence of the needle tips along with any lengths of suture carriedby the needles may be seen particularly converging upon or in proximityto the stylet channel 100 through which stylet 89 may be translated.

FIGS. 8A and 8B further illustrate detail perspective views of theproximal and distal ends of the assembly. The connection betweenactuation handle 82 to actuation shaft 84 may be seen while a distal endplate 102 is further shown in FIG. 8B with the actuation shafts 84, 86passed through the housing 90. The range of motion through which theactuation handles may rotate may be adjusted via any number ofmechanisms such as by set screws as shown in this variation. FIGS. 9 and10 also illustrate perspective and end views of the housing 90 in thisvariation. The tissue receiving channel 94 is shown as well as theneedle guides 44A, 44B for each of the needles. The stylet channel 100is also illustrated defined through the length of the housing 90 wherethe stylet channel 100 is coincident with the longitudinal axis inproximity to where each of the needle distal tips converges.

FIGS. 11A and 11B illustrate perspective views of the housing 90 whereeach of the needles is partially deployed. The curved or arcuate needlesare shown as having been at least partially rotated from their deliveryconfiguration to their deployed configuration. The needle piercing tipsare also shown with a stylet clearance slot 110 defined along eachneedle body proximal to the piercing tip. The stylet clearance slot 110provides for passage of the stylet 89 in proximity to the deployedneedles when the stylet 89 is used to pass the suture through the sutureloops passed by each needle through the tissue, as described in furtherdetail below.

FIG. 12 illustrates a perspective view of the needle assembly removedfrom the housing 90. The individual needles 96A, 96B are shownpositioned along their respective needle shafts 84, 86.

FIG. 13 illustrates yet another variation of an adjustable housingassembly which has two adjacent housing assemblies 112A, 112B defining atissue receiving channel 114 therebetween. The housing assemblies 112A,112B may be movably adjusted relatively away or towards one another toaccommodate various size tissues 66 to be treated. Moreover, theadjustability of the housing assemblies 112A, 112B may also allow forthe tissue 66 to be stabilized relative to the housing assemblies 112A,112B by temporarily clamping the assemblies upon the tissue 66 while theneedles and suture are driven into and through the tissue 66.

FIG. 14 illustrates another variation in the perspective view of tissuerepair assembly 120. This variation utilizes an adjustable dual housingconfiguration having a first adjustable housing 122A and a secondadjustable housing 122B which are coupled to one another via one or morebiasing members 128, e.g., one or more springs. Each of the adjustablehousing 122A, 122B may present a rounded or curved atraumatic outersurface with a first tapered member 124A positioned upon a distal end ofthe first housing 122A and a second tapered member 124B positioned upona distal end of the second housing 122B. The tapered members 124A, 124Bmay present a smooth angled surface to facilitate the insertion of theassembly 120 through the incision and into the subcutaneous tissuespace. The proximal end of the housing 122A, 122B may have any number ofactuatable handles attached although the handles are shown with arespective first handle 126A and second handle 126B extendingtransversely relative to the housing 122A, 122B.

The adjustable tissue receiving channel 130 may be defined between eachof the first and second housing 122A, 122B where a force F (such as bymanual manipulation by the practitioner) may be applied to press thefirst and second handles 126A, 126B towards one another, as indicated bythe direction of force application. Force F applied to the handles 126A,126B may urge the housing 122A, 122B to pivot about biasing members 128away from one another and enable the housing 122A, 122B to adjust toaccommodate various size tissues positioned along the tissue receivingchannel 130. Because the one or more biasing members 128 may apply aconstant biasing force, the housing 122A, 122B may clamp upon the tissuewithin the receiving channel 130 to temporarily secure the tissue andinhibit relative movement between the tissue and housing during needleand suture deployment.

FIGS. 15A and 15B illustrate partial cross-sectional end views of thetissue repair assembly 120 to show how the housing 122A, 122B may beadjustable relative to one another as well as to show how the needleassemblies may traverse through the tissue receiving channel 130. Asshown, the needles 96A, 96B may be formed to have a curved or arcuateshape, e.g., semi-circular, where the needle body curves into a piercingdistal tip from a proximal end which forms a needle support arm 140A,140B configured to extend transversely relative to the needle body. Theneedle support arm 140A, 140B may define an opening through which theactuation shaft passes. During device insertion and placement within thepatient, the needles 96A, 96B may be retracted into their deliveryposition where the needles 96A, 96B are contained entirely (or at leastpartially) within their respective housing 122A, 122B, as shown in FIG.15A.

Once the repair device has been inserted in proximity to the tissueregion to be treated, the housing 122A, 122B may be articulated viaactuation handles 126A, 126B such that the housing 122A, 122B pivotsabout the one or more biasing members 128 to place the presentationsurfaces 146A, 146B defining the tissue receiving channel 130 securelyaround the tissue of interest. With the tissue positioned within thetissue receiving channel 130, the housing 122A, 122B positioningrelative to the tissue may be further adjusted, if so desired. Each ofthe needles 96A, 96B may have one or more lengths of suture positionedalong each needle body and between each adjacent needle, as described infurther detail below. Once the device has been desirably positionedrelative to the tissue, the needles 96A, 96B may be actuated(simultaneously or sequentially, as described above) such that theneedles 96A, 96B are rotated by the actuation shafts 142A, 142B. Thepiercing tips of the needles 96A, 96B may accordingly exit the needleopenings 148A, 148B defined along the presentation surfaces 146A, 146Band traverse through the tissue receiving channel in a circular curve orarc trajectory, as shown in FIG. 15B.

As the needles 96A, 96B traverse through the channel 130 and tissue, theneedles may pass the suture loops through the tissue and into proximityto the stylet channels 144A, 144B defined longitudinally throughrespective housing 122A, 122B. As previously described, the needles 96A,96B may define a notched or cut-out section as a stylet clearance slot110 which aligns with the stylet channels 144A, 144B when the needles96A, 96B have been fully rotated into their deployed configuration. Oncethe needles 96A, 96B have carried the suture lengths and suture loopsthrough the tissue and into proximity to the stylet channels 144A, 144B,the stylet (which carries a length of the suture) may accordingly bepassed through the stylet channel 144A, 144B to route the suture throughthe suture loops for further tightening of the suture upon the tissue.Once the suture loops have been passed via the needles 96A, 96B, theneedles may be retracted proximally back through the tissue and into thehousing 122A, 122B for disengaging the tissue and subsequent removal ofthe device from the tissue region.

FIGS. 16A and 16B show partial cross-sectional side views of anothervariation where the respective housing 122A, 122B may be coupled to oneanother and adjusted accordingly via an adjustable hinge or pivot 150.The hinge or pivot 150 may allow for the pivotal and/or translationaladjustment of the housing 122A, 122B relative to one another, as shownin this example.

Turning now to FIG. 17, an example of how the suture may be routedthrough the housing and between each adjacent needle is shown in theperspective assembly view. As described herein, each of the needles maycarry a length of suture and/or suture loops for passage through thetissue. The suture may be comprised of individual lengths of suture or asingle contiguous length of suture may be routed through the housingbetween each adjacent needle. In this variation, with the needleassembly retracted in its delivery configuration within the housing122B, a single length of suture 160 may be routed towards a proximal endof a first needle 162 which may define a suture guide channel 166 alongan outer circumference of the needle from where the needle body extendsfrom the needle support arm 164 towards the needle tip 168. The suture160 may be guided along this suture guide channel 166 such that thesuture 160 extends along the needle body towards a suture guide exit 170which may comprise a channel or groove along the needle body proximal tothe needle tip 168. Although the suture guide exit 170 is shown as achannel which is transverse to the needle body, other configurations maybe utilized.

As the needle rotates into its deployed configuration, the suture guidechannel 166 and suture guide exit 170 helps to maintain the sutureposition along the needle body, particularly as the needle and suturepasses through the tissue. Moreover, the suture guide exit 170 may helpto push the suture 160 through the tissue and then enables the suture160 to be released from the needle guide exit 170 as the needle isretracted to leave the suture 160 length behind.

Once the suture 160 passes through the suture guide exit 170 of firstneedle 162, the suture 160 is further routed towards the adjacent secondneedle 172. The suture 160 may enter suture guide channel 174 and passalong the needle body towards the suture guide exit 178 of the secondneedle proximal to the needle tip 176. The suture 160 may then continueto the adjacent third needle 180 where the suture similarly enters thesuture guide channel 182. As with the second needle 172, the suture 160may be routed along the suture guide channel 182 until it passes throughsuture guide exit 186 proximal to the needle tip 184. The suture 160 maythen be further routed proximally where a terminal end (or a portion) ofthe suture 160 may be passed along the stylet 89 for passage through thestylet channel and for tightening to the tissue.

FIG. 18 illustrates a partial assembly view of another variation of thetissue repair assembly having a dual housing 122A, 122B configuration.Each housing 122A, 122B is shown extending from a respective firsthousing support 190A and second housing support 190B which are pivotablycoupled to one another via a pivot 192. The first and second housingsupport 190A, 190B may enable the housing 122A, 122B to be adjustedrelative to one another while the actuation handle may be coupled to theneedle actuation shaft 194 for deploying the needle assemblies.

Also shown is a single needle 196 having piercing tip 198. As the shaftis actuated, as indicated by the direction of handle actuation 200, thecorresponding direction of needle actuation 202 illustrates how the oneor more needles 196 may be actuated to rotate with shaft 194 to traversethe piercing tip 198 and suture carried by the needle into and throughthe tissue positioned within tissue receiving channel 130. Thisvariation illustrates an embodiment where each housing 122A, 122B mayutilize its own corresponding stylet 89. For a dual housing embodiment,two individual stylets may be used where the needle assembly within asingle housing may converge along its respective stylet channel. Asingle stylet 89 is shown passing through the stylet channel of secondhousing 122B while the corresponding stylet which passes through thestylet channel of first housing 122A is omitted for clarity only. Hence,each needle assembly within each housing 122A, 122B may deploy aseparate length of suture which may be tightened against the treatedtissue. Alternatively, a single length of suture may pass through bothneedle assemblies within each housing 122A, 122B for deploying a singlecommon suture through both needle assemblies.

FIGS. 19A and 19B illustrate end views of another variation where thedual needle assemblies may converge along a single stylet channel foruse with a single stylet. In this example, as the first needle 210A andsecond needle 210B are deployed for passage through the tissue receivingchannel 214 and the tissue, the first stylet clearance slot 212A offirst needle 210A and the second stylet clearance slot 212B of secondneedle 210B may align with one another within the housing 216 with thestylet channel and stylet 89 which may pass through each of theclearance slots of each needle. The stylet 89 may be separated at adistance 218 between the stylet 89 and the tissue receiving channel 214to ensure that adequate spacing is provided between the tissue surfaceand the suture loops for tightening.

Moreover, as shown in the detail end view of FIG. 19B, when the styletclearance slot is aligned with stylet 89, the suture guide exit 224proximal to the needle tip 222 may be aligned at a distance from thestylet 89 to ensure that adequate suture-to-stylet separation 226 existsto reduce any risk of the suture 160 catching upon the needle duringsuture release when the needle with withdrawn proximally. Accordingly,as the suture passes over the suture guide channel 220 along the needlebody and exits the suture guide exit 224, the exiting suture 160 may beseparated at a distance from the style 89.

Alternative variations of the needle and suture guide are further shownin the end views of FIGS. 20A and 20B. In this variation, needle 230 isillustrated as having a stylet clearance slot 232 which provides arelatively deeper recess along the needle body as well as a furtherseparation from the suture guide exit 234 to further move the sutureaway from the stylet to prevent suture puncturing compared to the needlevariation of FIG. 19B. The clearance between the suture guide exit 234and the clearance slot 232 may accordingly be increased as desired.

FIGS. 21A and 21B illustrate end and perspective views of yet anotherneedle variation where the needle 240 is provided with a deeper suturegroove 246 relative to the needle variation of FIG. 19B. The suturegroove 246 may extend between the suture guide exit 244 and styletclearance slot 242 to further retain the suture to prevent wedging ofthe suture between the needle body.

Yet another variation is illustrated in the end and perspective views ofFIGS. 22A and 22B which show a needle variation 250 having an additionalside cutout to further provide a path for the suture to prevent wedgingof the suture. The suture guide exit 254 may be provided distal to thestylet clearance slot 252 but an additional suture groove 256 may beprovided along the needle body proximal to the stylet clearance slot252. The suture may be routed along the outer channel of the needle bodyand then pass through the suture groove 256 towards an inner portion(e.g., towards the inner diameter) of the needle body where the suturemay then pass through suture guide exit 254. Alternatively, the suturemay be routed either along the inner diameter or outer diameter of theneedle body and pass accordingly through both the suture groove 256 andsuture guide exit 254 in an alternating manner.

In yet another variation, the needle 260 may be provided with a needleprojection 264 proximal to the stylet clearance slot 262, as illustratedin the end view of FIG. 23. The needle projection 264 may be an enlargedportion of the needle body extending from an inner diameter of theneedle and may function to guide the suture 160 well around the stylet89 to prevent or minimize contact between the two.

Turning now to mechanisms for needle actuation, FIG. 24A illustrates anend view of one variation for rotating actuation shaft 84 to in turnrotate the needle assembly 272 within housing 270. An actuation handlemay be directly coupled to a proximal end of the actuation shaft 84, asdescribed above, but another variation may utilize a pinion gear 274attached to a portion of the actuation shaft 84. A rack 276 attached toan actuation handle may have one or more gear teeth 278 which may beoperatively coupled to the gear teeth of pinion gear 274. As the rack276 is translated along the direction of translation 280 by theactuation handle, the pinion gear 274 may rotate accordingly to deployand/or retract the needle assembly depending upon the direction oftranslation 280.

FIG. 24B illustrates another variation in the end view of actuationshaft 84. In this variation, at least one cable 292 may be wound arounda pulley 290 attached to actuation shaft 84. The cable 292 may becoupled to an actuation handle which may pull the cable 292 along thedirection of actuation 294 to rotate the actuation shaft 84. Deploymentand/or retraction of the needle assembly will depend upon the directionof cable actuation.

FIG. 25 schematically illustrates an example of how a cable assembly maybe operatively coupled to an actuation handle for deploying and/orretracting the needle assembly. In this example, the actuation handle 16may be coupled to a pulley 304 via a shaft 302. Pulley 304 may havecable 292 attached at one or more attachment points 306. The resultingcoupled pulleys 300 may thus transfer a rotational movement from theactuation handle 16 into a linear translation along the attached cable292. The length of the cable 292 may be passed or routed over one ormore pulleys 308 to alter the direction of the cable 292 so as toaccommodate the configuration of the tissue repair assembly. The cable292 may be wound or otherwise attached to the actuation shaft 84 viapulley 290, as described above. As the actuation shaft 16 moves thecable 292 in one of two linear directions, the pulley 290 may rotateaccordingly and thus rotate actuation shaft 84 in a corresponding mannerto deploy and/or retract the needle assemblies.

Aside from the rotation of the needles, the handle assembly 310 mayitself be adjustable to facilitate placement and securement of thesuture assembly relative to the tissue. FIG. 26A illustrates aperspective view of one variation for temporarily securing the handleassembly 310 upon a portion of tissue. In this variation, the suturedelivery assembly 312 may define the tissue receiving channel 314between the housing members. Each housing member may be attached to afirst handle portion 316A and a second handle portion 316B within ahousing. A wire or cable 322 may be attached to each of the handleportions 316A, 316B where a first end of the wire or cable 322 isattached to an actuator 318, shown as a rotatable knob in thisvariation, and the second end of the wire or cable 322 may be anattached to an attachment point 320 along at least one of the handleportions 316A, 316B.

Once the tissue has been desirably positioned along tissue receivingchannel 314, the actuator 318 may be rotated in the direction ofactuation 324 to tighten the wire or cable 322 and draw the handleportions 316A, 316B towards one another and thereby securing the suturedelivery assembly 312 upon the tissue region, as indicated by thearrows.

FIG. 26B illustrates another variation where the handle portions 316A,316B may be attached to a respective first scissor handle 330A and asecond scissor handle 330B which may be rotationally coupled to oneanother via a pivot 332. As the scissor handles 330A, 330B are squeezedalong the direction of actuation 334, the handle portions 316A, 316B maycorrespondingly clamp upon the tissue region. Movement of the scissorhandles 330A, 330B in the opposite direction may correspondingly releasethe handle portions 316A, 316B from the tissue region.

FIG. 26C illustrates a perspective view of yet another variation where ahandle actuation member 340 may be attached to handle portions 316A,316B. An optional handle 342 may be attached to member 340 such that asthe handle 342, e.g., pulled in the direction of actuation 344, themember 340 may function to draw handle portions 316A, 316B towards oneanother to secure the assembly onto the tissue region. FIG. 26D showsanother variation where the handle 342 may be replaced with a ringhandle 350.

With respect to the variations shown in FIGS. 26C and 26D, an example isillustrated in the schematic end view of FIG. 26E showing the degree ofmovement sufficient for securely placing the suture delivery assembly312 upon the tissue region within tissue receiving channel 314. Theadjustable housing members may move relative to one another whenfunctioning as a clamping mechanism for securing the tissue to betreated. The housing members may thus rotate relative to a rotationalpoint 360 where the rotational radius 362 extends from the rotationalpoint 360 to a longitudinal axis of the tissue repair assembly. Thedegree of rotation 364 that one housing member may rotationally adjustrelative to the remaining housing member may vary to less than about 4degrees to effectively clamp onto the tissue within tissue receivingchannel 314.

To effectuate the rotational adjustment, an example of one mechanism isschematically shown in FIG. 26F which may be integrated into the handleassembly of a tissue repair assembly. The handle actuation assembly 370may incorporate the handle actuation member 340 which is manipulatableby the user. The actuation member 340 may be pivotably coupled to afirst member 372A and a second member 372B via a respective first pivot374A and second pivot 374B. Each of the first and second members 372A,372B are in turn coupled to a first handle coupling member 376A and asecond handle coupling member 376B which are also coupled to another viaa pivot 378. The first and second handle coupling members 376A, 376B maybe attached to a respective housing member such that when handleactuation member 340 is translated, each of the first and second members372A, 372B may be urged along a direction of actuation 380 which in turnforces the first and second handle coupling members 376A, 376B towardsone another in the direction of handle clamping 382 as they rotate aboutpivot 378. This variation is illustrative of one mechanism for actuationthe housing assembly while other embodiments are also possible.

Turning now to the needle assemblies, another variation is shown in theperspective view of needle assembly 390 where the needles 392 may extendin a curved or arcuate configuration from a corresponding base 394having a guide 396 which may project radially for alignment through theneedle housing. The number and relative positioning of the needles maybe varied although the three needles are shown along each side. Theneedles are illustrated in a staggered and alternating configuration;however, the needles may be more closely aligned such that the needletips are immediately adjacent to one another. Alternatively, the needlesmay be arranged in a staggered configuration farther apart from oneanother depending upon the desired suturing pattern.

Regardless of the number of needles used and the relative positioning ofthe needles, the needles may be configured and positioned relative tothe tissue receiving channel such that the needles may penetrate intoand through any number of varying tissue sizes. As illustrated in theend view of FIG. 28, an exemplary needle body 400 which is curved orarcuate (as described herein) may be positioned to penetrate a range oftissue sizes. Shown are representative cross-sectional views of tissuesof varying sizes which are superimposed upon one another for comparison.For example, a tissue having a relatively small diameter such as atendon 406 having 0.5 cm diameter is shown in comparison to a tendon 408having 1 cm diameter as well a tendon 410 having 2 cm diameter.Regardless of the tissue size, the tissue may be positioned within thetissue receiving channel such that when the needle is deployed, itspiercing tip 402 may enter the tissue through a tissue entry 412 along aside portion of the tissue and pierce through the tissue at a tissueexit 414 located along a top portion of the tissue where the side andtop are relative to the tissue position relative to the tissue receivingchannel.

As shown, the needle may pass a length of suture 160 carried via thesuture guide exit 404 entirely through the tissue regardless of tissuesize. With the suture 160 passed through, the stylet 89 may beintroduced through the suture loop formed by the suture 160 and leftwhen the needle piercing tip 402 is retracted and the suture 160 fallsout of the suture guide exit 404.

Alternative variations of the needle distal assembly are illustrated inthe side views of FIGS. 29 and 30. FIG. 29 shows a needle 420 having aneedle body 422 with a piercing tip 424 and a suture guide exit 426where the suture guide is formed with a split piercing tip 424. FIG. 30shows a needle 430 having a needle body 432 where the suture guide exit436 may be formed between a dual-pronged piercing tip 434.

FIGS. 31A and 31B illustrate end and detail side views of yet anothervariation of a needle where the needle body 440 may curve from a needlebase 448 which is configured to abut the needle actuation shaft. Thepiercing tip 442 extends along a circumference of the needle with thesuture guide exit 446 formed proximal to the tip 442 and extendsproximally towards the stylet clearance slot 444 where the clearanceslot 444 is defined along an inner circumference of the needle body. Thepiercing tip 442 may be formed over circumference which may extend,e.g., about 180° relative to the needle base 448.

FIGS. 32A and 32B illustrate yet another variation where the needle body450 similarly curves from the needle base 448 but where the piercing tip442 is formed at a distal end of a needle body 450 which is relativelonger than the needle body 440 of FIG. 31A. The increased angle 454resulting from the extended needle body 450 may extend, e.g., about 20°more than the needle body 440. Moreover, the suture guide exit 452 maybe formed to extend farther proximally within the needle body 450 thanthe suture guide exit 446 of FIG. 31A to facilitate securement of thesuture during passage through the tissue.

FIGS. 33A and 33B illustrate detail end and perspective views of avariation of the needle to show the relative positioning. With theneedle 460 pierced through the tissue, suture guide 462 may be seenpushing the suture 160 length through the tissue to create a suture loopwhen needle 460 is retracted. The stylet clearance slot 464 provides arelatively small recess for the stylet 89 to pass under the suture loop.

FIGS. 34A and 34B illustrate detail end and perspective views of yetanother variation where the needle body may form a slot 470 whichextends at least partially along the needle from a slot opening 472 atthe suture guide exit 462, through the stylet clearance slot 464, andpartially beyond. In this variation, the stylet 89 may be left in placethrough clearance slot 464 and the needle 460 may be retracted such thatthe stylet 89 and/or suture along the stylet passes through slot 470 andout through slot opening 472.

FIGS. 35A to 35C illustrate detail end and various perspective views ofanother variation where the needle 460 may incorporate a suture guidancearm 480 which extends transversely from an inner circumference of theneedle body such that the guidance arm 480 projects radially inwardsrelative to the needle 460 curvature. The suture guidance arm 480 may becomprised of a variety of materials which are elastic or flexible, e.g.,Nickel-Titanium alloys such as Nitinol, spring stainless steels, etc.The guidance arm 480 may be positioned proximal to the suture guidanceexit 462 and project at a distance to form a curved suture receivingsegment 482. With the suture 160 positioned along the suture guidanceexit 462, a portion of the suture 160 may pass along the guidance arm480 which may keep the suture 160 away from the inner surface of theneedle body.

As the needle 460 is passed through the tissue with the suture 160, thesuture guidance arm 480 may flex or bend proximally along the needlebody but when the guidance arm 480 is free from the constraints of thetissue, the guidance arm 480 may reconfigure itself into itsunconstrained configuration (as indicated by the direction of armmovement 484) and push the suture 160 out. Likewise, when the needle 460is retracted proximally through the tissue, the suture guidance arm 480may flex or bend distally along the needle tip releasing the suture 160as well as facilitating removal of the needle 460 from the tissue.

FIGS. 36A and 36B illustrate yet another variation in the end andperspective views of a needle 490 which may be formed as having a firstretractable petal 492A and a second retractable petal 492B which areapposed to one another to form a stylet channel 496. Each of the petals492A, 492B may be formed from extensions of the needle body which curveoutwardly and then taper towards one another joining along a contactsurface 494 to collectively form a piercing tip. The stylet channel 496defined between the petals 492A, 492B may be sufficiently sized indiameter to receive a stylet 89 passing entirely through the channel496.

Moreover, each of the petals 492A, 492B may further define a sutureguide groove 498 which is defines a curved or arcuate groove or channelfor receiving the suture 160, as shown in FIG. 36C. Hence, as the needle490 passes through the tissue, suture 160 may reside over suture guidegroove 498 to be pushed through the tissue. With the needle tip andsuture 160 residing through the tissue, the stylet 89 may be passedthrough the stylet channel 496 and the needle 490 may be retractedrelative to the stylet 89 and/or stylet suture such that the petals492A, 492B open around the stylet 89 and release the stylet 89 and/orsuture from the stylet channel 496 thus leaving the suture loop behind.

Yet another variation of the needle is illustrated in the perspectiveview of FIG. 37 which shows a needle 500 having a piercing tip as wellas a cutting edge 502 formed with a secondary cutting edge 504 proximalto the distal tip. The suture guide 506 and stylet clearance slot 508may be seen proximal to the cutting edges 502, 504. The cutting edge 502and secondary cutting edge 504 may be formed such that the cutting edgesare planarly aligned with the needle body. Moreover, the cutting edges502, 504 may facilitate the cutting through of the tissue to prevent anyelastic effects of the tissue from collapsing the pierced opening.

FIG. 38 illustrates a perspective view of yet another needle variation.In this example, the piercing tip may also incorporate a cutting edge510 where the edge is formed transversely relative to the needle body.Having the transverse cutting edge 510 may prevent the tissue duringneedle retraction from catching on the suture guide exit 506.Additionally, a sharpened tip 512 may also be incorporated along thesuture guide exit 506 to further cut and minimize any tissue that mightotherwise catch on the suture guide exit 506.

In yet another variation of the tissue repair assembly, FIGS. 39A to 39Cshow alternative perspective views of a suture delivery assembly 520which may be configured to provide a visual indication of when theneedles have completely traversed through the tissue being treated. Theassembly 520 includes first and second housing 522A, 522B which may beattached to a respective first and second housing support 524A, 524Bwhich are in turn attached to one another via pivot 526. An adjustmentmember 534 such as a knob may be provided at pivot 526 to tighten toadjustably maintain a position of the first and second housing supports524A, 524B, e.g., when the housing 522A, 522B are to be secured upon thetissue region to be treated along tissue receiving channel 528

A respective first and second stylet channels 530A, 530B may be definedalong a proximal surface of each of the housing 522A, 522B through whichthe respective stylets may be inserted and advanced, as previouslydescribed. A first and second rotational stylet guide 532A, 532B may becoupled to respective needle actuation shafts and may each define anopening, groove, or channel along a periphery of the guide 532A, 532B,as shown in the perspective view of FIG. 39B. As the needle shaftsrotate, the guides 532A, 532B may rotate accordingly and align with therespective channels 530A, 531B when the needles have passed entirelythrough the tissue. When the guides 532A, 532B have aligned with theirrespective channels 530A, 530B, this may serve as an indicator andconfirmation to the practitioner that the assembly 520 is ready toreceive the stylets for tightening of the delivered suture lengths.

Additionally and/or alternatively, one or more locking screws 536 (orother mechanism) may be provided along either the first or secondhousing support 524A, 524B to provide for manual adjustment of theassembly 520 relative to the tissue. Moreover, each of the guides 532A,532B and/or respective needle actuation shafts may also be adjustedmanually as well, e.g., by engaging the guides 532A, 532B with aninstrument and rotating manually for adjusting one or both the guides,as shown in the perspective view of FIG. 39C.

In yet another variation of the tissue repair assembly, FIG. 40A shows avariation of the tissue repair assembly 540 having a handle assemblywhich may be used with either a lengthened suture delivery assembly 542(e.g., having an opening length to accommodate 1.5 cm of tissue) for useon the superior tissue portion and a shortened suture delivery assembly544 (e.g., having an opening length to accommodate 0.75 cm of tissue)for use on the inferior tissue portion connected to the heel of thepatient. The suture delivery assembly 542 or 544 may each be coupled tothe assembly with a respective first and second connector 556A, 556Bwhich may allow for the secure attachment and/or detachment of thesuture delivery assembly 542 or 544.

This variation may also provide for an actuation handle assembly 554which is coupled along a side portion of the assembly 540 so that thepractitioner may view the incision and tissue during a repair procedurewithout the handle assembly obstructing the view. The suture deliveryassembly 542 or 544 may be attached to a respective first connectorassembly 546 and second connector assembly 548 which are adjustablycoupled to one another via an adjustment shaft 550 extending between thetwo. An adjustment control 552 may be actuated or manipulated at thediscretion of the practitioner to adjust a distance between theconnectors 546, 548 which may also control or adjust a relative widthbetween each of the housing members for placement and securement overthe tissue to be treated. Once the width between the housings of thesuture delivery assembly has been desirably adjusted and secured uponthe treated tissue length, the handle assembly 554 may be actuated tourge the needle assemblies positioned within the suture deliveryassembly to rotate and pass through the tissue secured temporarilybetween the suture delivery assembly.

FIG. 40B shows a perspective view of the tissue repair assembly 540having the lengthened suture delivery assembly 542 attached viaconnectors 556A, 556B to the respective connector assemblies 546, 548.Similarly, FIG. 40C shows a perspective view of the tissue repairassembly 540 having the lengthened suture delivery assembly 542disconnected and the shortened suture delivery assembly 544 attachedinstead. Hence, the practitioner may first secure the suture to theproximal tissue length to the treated by using the tissue repairassembly 540 having the lengthened suture delivery assembly 542. Thenthe practitioner may decouple the lengthened suture delivery assembly542 and replace it with the shortened suture delivery assembly 544 forsecuring the suture to the distal tissue length. The suture lengths maythen be tensioned to approximate the torn or damaged tissue ends towardsone another and the suture may then be secured to one another once thetissue ends have been suitably positioned in proximity to one another.

Alternatively, the shortened suture delivery assembly 544 may beutilized first with the tissue repair assembly 540 to secure the distaltissue length and then the lengthened suture delivery assembly 542 maybe utilized to subsequently secure the proximal tissue length. In yetanother alternative, the lengthened suture delivery assembly 542 may beused along the distal tissue length while the shortened suture deliveryassembly 544 may be used along the proximal tissue length. In yetanother alternative, the lengthened suture delivery assembly 542 may beused for both the distal and proximal tissue lengths or the shortenedsuture delivery assembly 544 may be used along for both the tissuelengths. Other contemplated variations may also be utilized with one orboth of the respective suture delivery assemblies 542, 544 in otherexamples.

FIGS. 41A to 41C illustrate respective side, end, and top views of thetissue repair assembly 540 illustrating the connector assemblies 546,548 and attached suture delivery assembly 542. A connector shaft 558adjacent to the adjustment shaft 550 may also be seen extending betweenthe connector assemblies 546, 548 to facilitate the translation of theassemblies 546, 548 relative to one another. The end and top views ofFIGS. 41B and 41C in particular illustrate how the handle assembly 554may be aligned to be in parallel with the connector assemblies 546, 548such that the view of the suture delivery assembly 542 remains visuallyunobstructed for facilitating the procedure.

When the tissue repair assembly 540 is actuated into its widenedconfiguration, it may have an extended width W, e.g., about 3.5 in. Thewidth of the adjustable tissue receiving channel 560 may be accordinglyadjusted via actuation of adjustment control 552 depending upon thewidth of the tissue to be treated. The length of the assembly 540 mayalso vary depending upon whether the shortened or lengthened suturedelivery assembly is connected. When the lengthened suture deliveryassembly 542 is coupled, the assembly 540 may have an extended length L,e.g., about 5.4 in. Also, the height H between the connector assemblies546, 548 and the height of the handle assembly 554 may have a height H,e.g., about 5.9 in., but this may be adjusted accordingly.

An example of the handle assembly 554 is shown in the side, end, andexploded assembly views of FIGS. 42A to 42C. While the handle assembly554 may be configured in a number of different embodiments, thisparticular variation illustrates a first and second handle 570A, 570Bwhich may be similarly shaped and sized adjacent to one another with atrigger handle 572 rotatingly positioned between handles 570A, 570B. Thetrigger handle 572 may be coupled to the handles 570A, 570B via a pivot574 at a first end of the handle assembly 554 and slidingly coupled at asecond end of the handle assembly 554. The adjustment shaft 550 may becoupled to both handles 570A, 570B and connector shaft 558 may bepositioned in proximity to the handle assembly 554. In use, when theneedle assembly is ready to be actuated for passage into the tissue, thetrigger handle 572 may be actuated relative to the first and secondhandles 570A, 570B to rotate a transverse shaft through the tissuerepair assembly which in turn may rotate the needle actuation shafts andneedles through the tissue, as described in further detail below.

FIGS. 43A to 43C show detail perspective, side, and end views of one ofthe connector assemblies to which the handle assembly 554 may becoupled. As shown in the perspective view of FIG. 43A, the connectorassembly 548 may generally comprise a body having a length (e.g., about3.94 in.), width (e.g., about 0.85 in.), and height (e.g., about 0.71in.) which further comprises an angled connector 582 which extends anddefines an opening 584 through which a needle actuation shaft may passthrough. The connector assembly 548 may define a receiving channel 580within which a bevel gear 586 may be rotatably secured upon a proximalend of a rotational shaft 588 which extends through the length of theassembly 548. The bevel gear 586 may be aligned longitudinally to rotateabout the shaft 588 and a distal end of the shaft 588 may be attached toa yoke 592 which in turn may be attached to a coupling 590, as shown inthe side view of FIG. 43B. The yoke 592 may allow for the rotation ofthe shaft 588 to be transferred to the coupling 590 through the angledconnector 582. A transversely aligned bevel gear 594 may also bepositioned at least partially within the receiving channel 580 such thatthe transversely aligned bevel gear 594 is operatively connected to thebevel gear 586, as shown in the end view of FIG. 43C.

FIG. 44 shows a detail perspective view of the repair assembly with theconnector assemblies removed for clarity. Once the first housingassembly 602A and second housing assembly 602B of suture deliveryassembly 600 have been desirably secured upon the tissue length to betreated, the handle assembly 554 may be actuated to rotate transverseshaft 604 about its axis, as illustrated. With the rotation of thetransverse shaft 604, the respective transverse bevel gears 594A, 594Battached to shaft 604 may rotate and engage the corresponding bevelgears 586A, 586B to transfer the rotational movement from transverseshaft 604 to rotational shafts 588A, 588B coupled to the respectivebevel gears 586A, 586B.

The respective yokes 592A, 592B may accordingly rotate in opposingdirections relative to one another and in turn rotate the attachedcouplings 590A, 590B. The couplings in turn may actuate the respectivefirst and second needle actuation shafts 606A, 606B and first and secondneedle assemblies 608A, 608B, as shown in the perspective view of FIG.45 which illustrates the needle assemblies with their housing removedfor clarity.

FIG. 46 shows an exploded assembly view of one of the housing assemblies602A. The housing 610 is shown defining tissue receiving channel 636with an atraumatic tip or nose cone 612 at its distal end. A suturebasket 614 may be positioned within a distal end of the receivingchannel 636, as also shown in the bottom view of FIG. 47A. With theneedle actuation shaft 618 positioned through the length of the housing610, the needles 608A (three needles shown in this variation) may bepositioned along the actuation shaft 618 spaced at uniform distancesfrom one another while a first and second spacer 616, 620 may also bepositioned along the actuation shaft 618 between the needles 608A. Inthis variation, the needles 608A may be spaced at a distance S1, S2 fromone another (e.g., 0.59 in. each). However, in other variations, thenumber of needles may be decreased or increased and the spacing betweenneedles (if two or more are used) may also be uniform or arbitrarydepending upon the desired results.

The connector 622 for coupling to the connector assembly may be securedat the proximal end of the housing 610 and two or more securement shafts624, 626 may be positioned along either side of the housing 610 forsecuring the components of housing 610, as shown in the bottom and endviews of FIGS. 47A and 47B. A stylet 628 may be seen positioned forinsertion through the housing 610, as previously described above, whilestylet catch 638 may also be incorporated within the housing 610 orsuture basket 614.

The suture basket 614 which may be positioned within the distal end ofthe receiving channel 636 is shown in further detail in the perspectiveviews of FIGS. 48A and 48B. The basket 614 shows the member having aC-shaped configuration which defines a suture receiving channel 630around an actuation shaft receiving channel 632. A stylet opening 634may be further defined through one or both ends of the basket 614.

One particular variation of the housing is illustrated in the side andperspective views of FIGS. 49A and 49B. As shown, the one or moreneedles 640A may be aligned within the receiving channel 636 but theneedle actuation shaft 642 may be offset to lie along one of the edgesof the receiving channel 636.

FIG. 50A shows an end view of the housing 610 having the atraumatic tip612 while FIG. 50B illustrates the needles 640A positioned in itslow-profile configuration. With the needle actuation shaft 642positioned along an edge of the receiving channel 636, because theactuation shaft 642 is no longer centrally located relative to theneedle 640A but is instead positioned along the periphery, rotating ofthe actuation shaft 642 results in a rotation of the needle 640A whichis eccentric relative to the housing 610. This eccentric path of theneedle tip allows for a greater purchase of tissue T within the samegiven volume, as shown in the end view of FIG. 50C, and also moreclosely replicates natural human suturing motion.

In one variation, the eccentric positioning allows for a cross-sectionalarea of tissue T purchased by the needle to exceed, e.g., 12-13.5 mm² ormore. For instance, utilizing a single suture length with three sutureloops with a desired pull strength of 22 lb through a cross-sectionalarea of tissue of, e.g., 6.3 mm², may be insufficient while a similarsuturing configuration through a cross-sectional area of tissue of atleast, e.g., 9.4 mm², may provide for a sufficient amount of tissue toresult in a pull strength of 22 lb. Having the increased amount oftissue T pierced and retained by the needle 640A may allow for such anincreased tensile force in the resulting suture configuration.

The applications of the disclosed invention discussed above are notlimited to certain treatments or regions of the body, but may includeany number of other treatments and areas of the body. Modification ofthe above-described methods and devices for carrying out the invention,and variations of aspects of the invention that are obvious to those ofskill in the arts are intended to be within the scope of thisdisclosure. Moreover, various combinations of aspects between examplesare also contemplated and are considered to be within the scope of thisdisclosure as well.

The invention claimed is:
 1. A tissue repair system, comprising: ahandle having an actuator; a suture delivery assembly coupled to thehandle and having a dual housing assembly including a first housing anda second housing which together define a tissue receiving channel, thefirst housing being moveable relative to the second housing; a stylettranslatable through the suture delivery assembly; a curved needle thatis rotatable from a delivery position at least partially through thetissue receiving channel to a deployment position when articulated bythe actuator, the curved needle defining a clearance slot which is sizedto partially receive the stylet when the needle is aligned relative tothe tissue receiving channel in the deployment position; and a length ofsuture carried on at least an outer portion of the needle, wherein thelength of suture defines a suture loop extendable from a distal tip ofthe needle.
 2. The system of claim 1, wherein the stylet comprises alength of suture.
 3. The system of claim 1, wherein the needle includesa suture groove between the distal tip and the clearance slot.
 4. Thesystem of claim 3, wherein the needle further includes an additionalsuture groove proximal to the clearance slot.
 5. The system of claim 1,wherein the tissue receiving channel is sized for receiving an Achillestendon.
 6. The system of claim 1, wherein the suture delivery assemblycomprises a needle housing having the needle therein aligned to rotatein a direction which is transverse to a longitudinal axis of the suturedelivery assembly.
 7. The system of claim 1, wherein the suture deliveryassembly is removable from the handle.
 8. The system of claim 1, furthercomprising a rotatable actuation shaft upon which the needle ispositioned.
 9. A method for repairing a tissue region, comprising:introducing a suture delivery assembly having a dual housing assemblyincluding a first housing and a second housing, which together define atissue receiving channel, through an incision in proximity to a rupturedor torn tendon tissue; moving the first housing relative to the secondhousing to clamp the ruptured or torn tendon tissue within the tissuereceiving channel; positioning a first portion of the ruptured or torntissue within the tissue receiving channel; rotating a needle from adelivery position within the suture delivery assembly to a deploymentposition such that the needle pierces into and through the tissuepositioned within the tissue receiving channel, where the needle furtherpasses a length of suture through the tissue; advancing a stylet throughthe suture delivery assembly and through a stylet clearance slot definedalong the needle; and securing the lengths of suture to the firstportion of tissue.
 10. The method of claim 9, wherein introducing thesuture delivery assembly comprises introducing the suture deliveryassembly through a single incision along a posterior region of a leg.11. The method of claim 9, wherein rotating the needle comprisesactuating a handle attached to a proximal end of the suture deliveryassembly.
 12. The method of claim 9, wherein rotating the needlecomprises actuating two or more needles simultaneously.
 13. The methodof claim 9, wherein the needle further defines a suture guide along theneedle proximal to a distal tip, the suture guide forming a suture loopalong the needle, and wherein advancing the stylet comprises passing asuture length through the suture loop.
 14. The method of claim 9,further comprising re-introducing the shaft into the incision inproximity to a second portion of the ruptured or torn tissue.
 15. Themethod of claim 14, further comprising approximating the first andsecond portions of the tissue towards one another and securing the firstand second portions.
 16. The method of claim 9, further comprisingclamping the suture delivery assembly to the ruptured or torn tissueprior to rotating the needle.